Arrow International, LLC (subsidiary of Teleflex, Incorporated)

Registration Details

Registration Name: Arrow International, LLC (subsidiary of Teleflex, Incorporated)
Registration Number: 3010532612
FEI Number: 3010532612
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: 16 Elizabeth Dr
City: Chelmsford
State: MA
ZIP: 01824
Country: US

Regulatory Submissions

510(k) Number: K990236

Owner / Operator

Firm Name: Arrow International LLC (subsidiary of Teleflex Incorporated
Operator Number: 2518433
Address: 3015 Carrington Mill Blvd.
City: Morrisville
State: NC
Postal Code: 27560
Country: US
Correspondent: Divya Raman

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	Class 2	General Hospital	No	2015-11-04
Catheter, Intravascular, Diagnostic	DQO	Class 2	Cardiovascular	No	2014-12-10
System, Balloon, Intra-Aortic And Control	DSP	Class 2	Cardiovascular	No	2007-02-05
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	Class 2	Cardiovascular	No	2007-12-13
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	Class 2	General Hospital	No	2007-02-06
Catheter, Flow Directed	DYG	Class 2	Cardiovascular	No	2007-12-13
Stents, Drains And Dilators For The Biliary Ducts	FGE	Class 2	Gastroenterology, Urology	No	2006-06-19
Cardiac Catheterization Kit	OES	Class 2	Cardiovascular	No	2025-12-10
Cardiovascular Procedure Kit	OEZ	Class 2	Cardiovascular	No	2010-11-19
Wire, Guide, Catheter	DQX	Class 2	Cardiovascular	No	2008-02-14
Electrode, Pacemaker, Temporary	LDF	Class 2	Cardiovascular	No	2008-02-15

Proprietary Names

Balloon Catheter RediGuard IABs ARROW INTRA-AORTIC BALL UltraFlex IAB RediGuard® Intra-Aortic Balloon System RediGuard® Intra-Aortic Balloon Catheter Arrow® QuadPolar Electrode Catheter Arrow® QuadPolar Mapping/Pacing Catheter AC3 Series Intra-Aortic Balloon Pump (IABP) AutoCAT®2 Intra-Aortic Balloon Pump, AutoCAT2WAVE® Intra-Aortic Balloon System AUTOPILOT® AutoCAT2WAVE® Intra-Aortic Balloon Pump, AutoCAT®2 Intra-Aortic Balloon System NarrowFlex® Intra-Aortic Balloon (IAB) System NarrowFlex® Intra-Aortic Balloon (IAB) Catheter UltraFlex® Intra-Aortic Balloon (IAB) Catheter, UltraFlex® Intra-Aortic Balloon (IAB) System Ultra 8® Intra-Aortic Balloon (IAB) System Ultra 8® Intra-Aortic Balloon (IAB) Catheter AC3 Range Intra-Aortic Balloon Pump PICC Balloon Thermodilution Catheter Arrow® Thermodilution Catheters Infusion Port Thermodilution FiberOptix® Intra-Aortic Balloon Catheter Kit AC3 Series IABP Arrow Berman Catheter, Arrow Berman Angiographic Catheter, Wedge Pressure Catheters and Reverse Berman Catheters Balloon Wedge Pressure Catheter LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERIZATION SETS Arrow® MultiPolar Electrode Catheter; Arrow® MultiPolar Mapping/Pacing Catheter Arrow® MultiPolar Mapping/Pacing Catheter Arrow® MultiPolar Electrode Catheter Intra-Aortic Balloon (IAB) Catheter AutoCAT®2 Intra-Aortic Balloon Pump (IABP) Fiber Optic System (FOS) FiberOptix® IAB Catheter, FIBEROPTIX® Intra-Aortic Balloon Catheter, Ultra 8® AutoCAT®2 Series AutoCAT®2WAVE Intra-Aortic Balloon Pump (IABP) ArrowTemporary Pacing Catheters and Kits Hands-off Thermodilution Catheters Internal Jugular Arrow® Wedge Pressure Catheter Kit Arrow® Thermodilution Catheter Kit Arrow® Berman Catheter Kit Arrow VPS AGBA PICC STAINLESS STEEL GEN PUR INTERVENTIONAL GUIDE WIRES AC3 Series IABP System AC3 AC3 Optimus Heparin Coated Thermodilution Ballo AC3 Series IABP System, AutoCAT®2 Intra-Aortic Balloon Pump Arrow® Temporary Pacing Catheters, Arrow® BiPolar Pacing Catheters Arrow® Wedge Pressure Catheter,

Establishment Types

Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer) Manufacture Medical Device